FDA.reportPublic FDA data

MAUDE MDR 5485208

MDR report key
5485208
Report number
1017522-2016-00004
Event key
0
Event type
3
Date of event
2016-01-26
Date received
2016-03-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
116
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. FRANK RAY
Address
11727 FRUEHAUF DRIVE CHARLOTTE NC 28273 US
Phone
704-704-7045
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LUXSTAR UNIT MOUNT LIGHTDENTAL OPERATING LIGHTMARUSEAZUL1000UL1000R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-0701. O

Event Narratives#

N

Patient 1

THE LENS HEAT SHIELD/HOLDER FROM THE DENTAL LIGHT HAS A THREE PRONG LOCKING MECHANISM WHICH LOCKS THE LENS HEAT SHIELD/COVER INTO PLACE. THE LENS HEAT SHIELD/COVER HAS TO BE REMOVED BY THE END USER WHEN CLEANING THE LENS OR REPLACING THE HALOGEN BULB DURING ROUTINE OPERATOR MAINTENANCE. THE INSTALLATION INSTRUCTIONS, USE AND CARE INSTRUCTIONS, AND LABELING CLEARLY STATE TO ENSURE THE LENS HEAT SHIELD/HOLDER IS PROPERLY SECURE BY SNAPPING THE PART BACK INTO PLACE. MARUS INITIATED A RECALL ON JUNE 10, 2011 TO ADD A TETHER TO THE LENS HEAT SHIELD/COVER TO KEEP IT FROM FALLING OFF THE DENTAL LIGHT IF IT IS NOT RE-INSTALLED PROPERLY. THE FDA CLOSED THIS RECALL ON 10/26/2012 (PLEASE REFERENCE FDA RECALL Z-2834-2011). MARUS NOTIFIED THE DISTRIBUTOR OF THE RECALL WHILE THE RECALL WAS OPEN. THE DISTRIBUTOR RESPONDED BACK TO MARUS AND ACKNOWLEDGED THE RECALL BUT APPARENTLY THE DISTRIBUTOR DID NOT INSTALL THE TETHER KIT AT THIS ONE PARTICULAR DENTAL PRACTICE. AFTER FOLLOWING BACK UP WITH THE DENTIST ON (B)(6) 2016, THE DENTAL PRACTICE INFORMED MARUS THE TETHER WAS INSTALLED ON THE DENTAL LIGHT ON (B)(6) 2016.

D

Patient 1

A DENTAL PROFESSIONAL WAS PERFORMING ROUTINE MEDICAL TREATMENT TO A PATIENT WHEN THE LENS HEAT SHIELD/HOLDER FELL OFF THE DENTAL LIGHT AND ONTO THE PATIENT'S NECK AND THEN TO THE FLOOR CAUSING A SMALL BURN TO THE PATIENTS NECK AREA. THE DR. PRESCRIBED A BURN CREAM BUT THE PATIENT REFUSED.